Urothelial CancerPhase 1NCT05279690
Pilot Trial of Colchicine in Urothelial Cancer and Other Solid Tumors
A Phase 1 study testing Colchicine in people with Urothelial Cancer and Metastatic Solid Tumor, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
This open-label, non-randomized study aims to determine the anti-inflammatory effect of colchicine on the reduction of peripheral blood CRP in patients with solid tumors or localized urothelial cancer. There are two cohorts, which will enroll separately and parallelly. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelial Cancer, Metastatic Solid Tumor
- What is being tested?
- Colchicine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2022to 16 Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
- Age ≥ 18 years at the time of consent.
- ECOG Performance Status of 0-1 within 28 days prior to registration. ECOG 2 is allowed for patients on Cohort 1.
- Cohort 1:
- Histological or cytologically confirmed solid tumor.
- Metastatic or recurrent disease
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- Elevated peripheral blood CRP level (> 5 mg/L) documented on routine bloodwork within 14 days or registration.
- Cohort 2:
- History of urothelial cancer post radical cystectomy, nephroureterectomy, or ureterectomy
- Eligible and planned for standard of care adjuvant nivolumab in the opinion of the treating investigator
- Elevated peripheral blood CRP level (> 5 mg/L) documented on routine bloodwork at a minimum of 30 days and a maximum of 120 days after surgical resection and within 14 days prior to registration.
- Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks (blocks preferred) or at least 15 unstained slides. If archival tissue is not available, enrollment will be considered on a case by case basis after discussion with the Principal Investigator.
- Demonstrate adequate organ function as defined below. All screening labs to be obtained within 14 days prior to registration.
- White blood cell (WBC) ≥ 2.5 K/mm3
- Absolute Neutrophil Count (ANC) ≥ 1.5 K/mm3
- Hemoglobin (Hgb) ≥ 8 g/dL
- Calculated GFR ≥ 50 cc/min or creatinine ≤ 1.5 mg/dl (The CKD-EPI equation will be used to calculate GFR)
- Bilirubin ≤ 1.5 × upper limit of normal (ULN) (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL)
- Aspartate aminotransferase (AST) ≤ 2.5 × ULN or < 5xULN for patients in Cohort 1 with liver metastases
- Alanine aminotransferase (ALT) ≤ 2.5 × ULN or < 5xULN for patients in Cohort 1 with liver metastases
- Females of childbearing potential must have a negative serum pregnancy test within 14 days prior to registration. See section 5.5 for definition of childbearing potential.
- Females of childbearing potential must be willing to abstain from heterosexual activity or to use an effective method(s) of contraception from the time of informed consent, during the study until after the last dose of study drug(s). Males must be willing to abstain from heterosexual activity or to use an effective method(s) of contraception from initiation of treatment until after the last dose of study drug(s).
- HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this trial.
- Patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, the HCV viral load must be undetectable to be eligible for this trial.
- As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.
Who cannot join
- Already taking long term colchicine for any other reason.
- Active infection requiring systemic therapy.
- Pregnant or breastfeeding.
- Prior cancer treatment must be completed at least 30 days prior to registration, or within 5 half-lives, and the subject must have recovered from all reversible acute toxic effects of the regimen (other than alopecia) to Grade ≤ 1 or baseline.
- Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen, per treating physician discretion, are not eligible for this trial.
- Active central nervous system (CNS) metastases.
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- Treatment with any investigational drug within 30 days prior to registration.
- Need for concomitant treatment with moderate or strong CYP3A4 inhibitors or P-gp inhibitors.
- Rheumatoid arthritis, vasculitis, systemic lupus erythematosus, or other autoimmune condition requiring active systemic treatment.
- Myocardial infarction within the prior last 6 months and/or ≥ Class III New York Heart Association heart failure.
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Colchicine to Suppress Pro-tumorigenic Inflammation in Patients with Urothelial Cancer and Other Solid Tumors
This open-label, non-randomized study aims to determine the anti-inflammatory effect of colchicine on the reduction of peripheral blood CRP in patients with solid tumors or localized urothelial cancer. There are two cohorts, which will enroll separately and parallelly. Cohort 1 will include two successive groups with advanced/recurrent solid tumors (15 patients will receive low-dose colchicine and 15 for high-dose colchicine) who will receive 14 days of colchicine. In Cohort 2, 15 patients with post-radical surgery for high-risk clinically localized urothelial cancer will be enrolled. They will receive one 28-day cycle of colchicine. The primary outcome, post-treatment decline in CRP level, a continuous measure, will be defined as the maximum percentage decline from baseline in post-treatment CRP value within two weeks of colchicine (Cohort 1) or one cycle of colchicine (cohort 2), where the baseline value is measured before any treatment is initiated.
- Conditions
- Urothelial Cancer, Metastatic Solid Tumor
- Being tested
- Colchicine
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColchicineDrug
Patients will receive 14 days of colchicine in the absence of prohibitive toxicity of disease progression
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 low-dose colchicine | Experimental | Participants with advanced/recurrent solid tumors who will receive low-dose colchicine (0.6 mg oral BID) Receives: Drug: Colchicine |
| Cohort 1 high-dose colchicine | Experimental | Participants with metastatic solid tumors who will receive high-dose colchicine (0.6 mg oral TID) Receives: Drug: Colchicine |
| Cohort 2 Participants with post-radical surgery | Experimental | Participants with post-radical surgery for high-risk clinically localized urothelial cancer will receive colchicine 0.6 mg oral BID. Receives: Drug: Colchicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Peripheral blood CRP level
The primary outcome, post-treatment decline in peripheral blood CRP level, a continuous measure, will be defined as the maximum percent decline of post-treatment CRP from baseline obtained during the treatment period, where the baseline value is measured before any treatment initiated For a patient with an advanced/recurrent solid tumor who receive 2-weeks of treatment, it will be the maximum percentage decline during the 28 days of treatment. For a patient who receive colchicine less than 28 days, it will be the maximum percentage decline from baseline to the last day of treatment.
Measured: Baseline and Within 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start14 Feb 2022
- Primary completion16 Dec 2024
- Study completion16 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urothelial CancerStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deborah Doroshow, Icahn School of Medicine at Mount Sinai
- Investigators
- Deborah Doroshow, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05279690
- Sponsor's protocol ID
- STUDY-21-01175
- Status last verified
- Dec 2024
- First submitted
- 5 Mar 2022
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Data will not be shared due to the small cohort size.
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colchicine to Suppress Pro-tumorigenic Inflammation in Patients with Urothelial Cancer and Other Solid Tumors
- ClinicalTrials.gov ID
- NCT05279690
- Acronym / sponsor ID
- STUDY-21-01175
- Conditions
- Urothelial Cancer, Metastatic Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 14 Feb 2022 (actual)
- Primary completion
- 16 Dec 2024 (actual)
- Study completion
- 16 Dec 2024 (actual)
- First posted
- 15 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This open-label, non-randomized study aims to determine the anti-inflammatory effect of colchicine on the reduction of peripheral blood CRP in patients with solid tumors or localized urothelial cancer. There are two cohorts, which will enroll separately and parallelly. Cohort 1 will include two successive groups with advanced/recurrent solid tumors (15 patients will receive low-dose colchicine and 15 for high-dose colchicine) who will receive 14 days of colchicine. In Cohort 2, 15 patients with post-radical surgery for high-risk clinically localized urothelial cancer will be enrolled. They will receive one 28-day cycle of colchicine. The primary outcome, post-treatment decline in CRP level, a continuous measure, will be defined as the maximum percentage decline from baseline in post-treatment CRP value within two weeks of colchicine (Cohort 1) or one cycle of colchicine (cohort 2), where the baseline value is measured before any treatment is initiated.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 low-dose colchicine | Experimental | Drug: ColchicineParticipants with advanced/recurrent solid tumors who will receive low-dose colchicine (0.6 mg oral BID) |
| Cohort 1 high-dose colchicine | Experimental | Drug: ColchicineParticipants with metastatic solid tumors who will receive high-dose colchicine (0.6 mg oral TID) |
| Cohort 2 Participants with post-radical surgery | Experimental | Drug: ColchicineParticipants with post-radical surgery for high-risk clinically localized urothelial cancer will receive colchicine 0.6 mg oral BID. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
- Age ≥ 18 years at the time of consent.
- ECOG Performance Status of 0-1 within 28 days prior to registration. ECOG 2 is allowed for patients on Cohort 1.
- Cohort 1:
- Cohort 2:
Key exclusion criteria (10 listed)
- Already taking long term colchicine for any other reason.
- Active infection requiring systemic therapy.
- Pregnant or breastfeeding.
- Prior cancer treatment must be completed at least 30 days prior to registration, or within 5 half-lives, and the subject must have recovered from all reversible acute toxic effects of the regimen (other than alopecia) to Grade ≤ 1 or baseline.
- Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen, per treating physician discretion, are not eligible for this trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ColchicinePatients will receive 14 days of colchicine in the absence of prohibitive toxicity of disease progression | Drug | Cohort 1 high-dose colchicine, Cohort 1 low-dose colchicine, Cohort 2 Participants with post-radical surgery |
Primary outcome
Percent Change in Peripheral blood CRP level
Time frame: Baseline and Within 28 days
The primary outcome, post-treatment decline in peripheral blood CRP level, a continuous measure, will be defined as the maximum percent decline of post-treatment CRP from baseline obtained during the treatment period, where the baseline value is measured before any treatment initiated For a patient with an advanced/recurrent solid tumor who receive 2-weeks of treatment, it will be the maximum percentage decline during the 28 days of treatment. For a patient who receive colchicine less than 28 days, it will be the maximum percentage decline from baseline to the last day of treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Individual participant dataSharing planned: No. Data will not be shared due to the small cohort size.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah Doroshow principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Colchicine in people with Urothelial Cancer and Metastatic Solid Tumor, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in Peripheral blood CRP level (time frame: Baseline and Within 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.